Vasopressin in Intraabdominal Pressure Elevation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Pain |
| Therapuetic Areas: | Musculoskeletal, Neurology |
| Healthy: | No |
| Age Range: | 18 - 72 |
| Updated: | 10/20/2018 |
| Start Date: | April 28, 2017 |
| End Date: | April 28, 2019 |
Correlation Between Vasopressin and Renal Function Following a Controlled Intraabdominal Pressure Elevation
The aim of this study is to investigate any direct correlation between increased
intrathoracic pressure, intraabdominal pressure and intracranial pressure, following a
controlled elevation in intraabdominal pressure and intrathoracic pressure (PEEP). The second
end-point is to investigate any correlation between elevated intracranial pressure and
vasopressin release, urine output and urine and serum osmolality by measuring their values at
different time-points.
intrathoracic pressure, intraabdominal pressure and intracranial pressure, following a
controlled elevation in intraabdominal pressure and intrathoracic pressure (PEEP). The second
end-point is to investigate any correlation between elevated intracranial pressure and
vasopressin release, urine output and urine and serum osmolality by measuring their values at
different time-points.
Increase in intraabdominal pressure (IAP) has been demonstrated to correlate with
consequential hemodynamic effects. Several studies have been carried out mostly in
experimental settings to define the underlying mechanisms that regulate the pathophysiology
following an increase in IAP. In the last years this topic has become concerning because of
the wide spread of laparoscopy, that is namely an iatrogenic acute increase in IAP.
Patients selected and consented for elective surgery will undergo standard of care and
additional measurements during and after surgery. The measurements will be done at different
stages of laparoscopic surgery.
1. A) Baseline, patient under general anesthesia, Foley catheter positioned, beginning
urine collection, before insufflation of pneumoperitoneum
2. B) 10-15 minutes after insufflation of pneumoperitoneum at 15mmHg, PEEP at 5cmH2O or
lowest setting
3. C) 10-15 minutes after stabilization of PEEP at 10cmH2O, pneumoperitoneum still at 15
mmHg
4. D) 10-15 minutes after desufflation of pneumoperitoneum and basal mechanical ventilation
Measurements include :
- Intraabdominal pressure IAP: assessed via laparoscopic insufflator, set at 15 mmHg as a
standard value for all laparoscopic procedures
- Intrathoracic pressure: indirectly measured by variability of peak expiratory pressures
- Urine collection: through a Foley catheter from the beginning of surgery to
post-operative day 1
- Urine osmolality (to be assessed at set time-points )
- Hourly urine output (at least 24 hours in order to evaluate expected significant
variation even after the procedure end, since renal adaptation could take longer period)
- Serum/plasma collection : blood draws to evaluate specific values of
- Plasma Vasopressin (ADH)
- Serum osmolality
- Mean arterial pressure : standard of care
- Pulmonary expiratory end-pressure (PEEP): anesthesiologists routinely adapt PEEP in
order to maintain an optimal ventilation, especially in obese patients and during
laparoscopy
- Optic nerve sheath diameter (ONSD): a 7.5-MHz linear ultrasound probe to measure the
diameter of the optic nerve sheath 3 mm behind the globe is going to be used; a trained
study personnel physician will take the non-invasive sonographic picture using
ultrasound. The ONSD will be measured from the captured picture. Study personnel will
record the interaction on the patient's chart and include the measurement on the
database
consequential hemodynamic effects. Several studies have been carried out mostly in
experimental settings to define the underlying mechanisms that regulate the pathophysiology
following an increase in IAP. In the last years this topic has become concerning because of
the wide spread of laparoscopy, that is namely an iatrogenic acute increase in IAP.
Patients selected and consented for elective surgery will undergo standard of care and
additional measurements during and after surgery. The measurements will be done at different
stages of laparoscopic surgery.
1. A) Baseline, patient under general anesthesia, Foley catheter positioned, beginning
urine collection, before insufflation of pneumoperitoneum
2. B) 10-15 minutes after insufflation of pneumoperitoneum at 15mmHg, PEEP at 5cmH2O or
lowest setting
3. C) 10-15 minutes after stabilization of PEEP at 10cmH2O, pneumoperitoneum still at 15
mmHg
4. D) 10-15 minutes after desufflation of pneumoperitoneum and basal mechanical ventilation
Measurements include :
- Intraabdominal pressure IAP: assessed via laparoscopic insufflator, set at 15 mmHg as a
standard value for all laparoscopic procedures
- Intrathoracic pressure: indirectly measured by variability of peak expiratory pressures
- Urine collection: through a Foley catheter from the beginning of surgery to
post-operative day 1
- Urine osmolality (to be assessed at set time-points )
- Hourly urine output (at least 24 hours in order to evaluate expected significant
variation even after the procedure end, since renal adaptation could take longer period)
- Serum/plasma collection : blood draws to evaluate specific values of
- Plasma Vasopressin (ADH)
- Serum osmolality
- Mean arterial pressure : standard of care
- Pulmonary expiratory end-pressure (PEEP): anesthesiologists routinely adapt PEEP in
order to maintain an optimal ventilation, especially in obese patients and during
laparoscopy
- Optic nerve sheath diameter (ONSD): a 7.5-MHz linear ultrasound probe to measure the
diameter of the optic nerve sheath 3 mm behind the globe is going to be used; a trained
study personnel physician will take the non-invasive sonographic picture using
ultrasound. The ONSD will be measured from the captured picture. Study personnel will
record the interaction on the patient's chart and include the measurement on the
database
Inclusion Criteria:
- Age 18-72
- Patients meeting NIH criteria for bariatric surgery
- Patients undergoing laparoscopic sleeve gastrectomy
Exclusion Criteria:
- • Age below 18 years
- American Society of Anesthesiologist (ASA) class IV or V
- Other evident/diagnosed causes of increased IAP or increased intrathoracic
pressure, except for obesity
- Active urinary tract infection
- Previous or concomitant neurological disease
- Previous or concomitant ophthalmic conditions/eye surgery
- Previous or concomitant lung diseases
We found this trial at
1
site
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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